RecruitingTachycardia, Ventricular

Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)

Eligible age

18+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

RADIATE-VT is a pivotal, multicenter, randomized trial comparing safety and efficacy between cardiac radioablation (CRA) using the Varian CRA System and repeat catheter ablation (CA), for patients with high-risk refractory ventricular tachycardia (VT) who have experienced VT recurrence after CA and are candidates for additional CA.

Sponsor: Varian, a Siemens Healthineers Company

You may qualify if…

✓ 1. High-risk refractory VT, defined as:
✓ 1. Ischemic and/or nonischemic cardiomyopathy, and
✓ 2. Recurrent sustained monomorphic VT, defined as at least one of the following below, documented by ICD interrogation or ECG in the prior 6 months, and having occurred after the last VT ablation:
✓ A: ≥3 episodes of monomorphic VT treated with anti-tachycardia pacing (ATP) at least one of which is symptomatic
✓ B: ≥1 appropriate ICD shock
✓ C: ≥3 episodes of sustained monomorphic VT within 24 hours treated with ICD shock or ATP
✓ D: sustained monomorphic VT below detection rate of ICD documented by ECG, and
✓ 3. Left ventricular ejection fraction (LVEF) ≤49% and

You may not qualify if…

✕ 1. Contraindication to a CA procedure for VT (e.g., presence of mobile LV thrombus, active systemic infection, active ischemic or other reversible causes of VT).
✕ 2. Patients with expected, right ventricular scar only.
✕ 3. Any prior radiation to the thorax region of the body.
✕ 4. Known medical conditions associated with higher risk of radiotherapy complications in the judgement of the radiation oncologist (i.e., active connective tissue disorders, interstitial lung disease, etc.) that would preclude safe delivery of CRA.
✕ 5. Current use of inotropes.
✕ 6. Presence of a left-ventricular assist device (LVAD).
✕ 7. Scheduled for LVAD or heart transplant procedures.
✕ 8. Presence of a systemic illness likely to limit survival to \< 1 year.